A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C

NCT00800748 | Completed Phase 4

• 2 other identifiers: ML193872005-003932-23
• Study Type: interventional
• Target: 372
• Locations: 2 countries
• Sites: 35

Brief Summary

This 3-arm study assessed the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants were studied; 1) those with elevated alanine transaminase (ALT) levels, 2) those with normal ALT levels, and 3) those with human immunodeficiency virus (HIV) co-infection. Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) once weekly (qw) + ribavirin 1000-1200 milligrams (mg) orally (PO) daily (dependent on body weight) for 48 weeks. Those with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks, and all participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virological Response

  Sustained virological response is defined as having no hepatitis C (HCV) virus detectable in the blood 24 weeks after end of treatment.

  Up to 72 weeks

Secondary Outcomes (3)

• Percentage of Participants With End-of-Treatment Virological Response

  Up to 48 weeks

• Percentage of Participants With Early-Treatment Virological Response

  Up to 12 weeks

• Percentage of Participants With Adverse Events

  Up to 72 weeks

Study Arms (3)

Group A

EXPERIMENTAL

Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 1000-1200 mg PO daily (dependent on body weight) for 48 weeks.

Drug: Peginterferon alfa-2a; Drug: Ribavirin

Group B

EXPERIMENTAL

Participants with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks.

Drug: Peginterferon alfa-2a; Drug: Ribavirin

Group C

EXPERIMENTAL

Participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.

Drug: Peginterferon alfa-2a; Drug: Ribavirin

Interventions

Peginterferon alfa-2a DRUG

Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.

Also known as: Pegasys

Group A; Group B; Group C

Ribavirin DRUG

Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.

Also known as: Copegus

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants at least 18 years of age
• Chronic hepatitis C, with detectable serum hepatitis C virus (HCV) ribonucleic acid (RNA)
• Scheduled for treatment with peginterferon alfa-2a
• Compensated liver disease
• Women in fertile age must be informed about obligation of using adequate contraception during and 6 months post treatment with ribavirin (Copegus®)
• Men with a sexual partner in fertile age must be informed about obligatory contraception preventing pregnancy during the course of treatment with ribavirin (Copegus®) as well as 6 months after treatment cessation

You may not qualify if:

• Chronic liver disease other than chronic hepatitis C
• Active hepatitis A virus or hepatitis B virus infection
• Therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment less than or equal to (\<=) 6 months prior to first dose of study drug
• Participants with increased risk of anaemia, or participants at risk of serious health problems resulting from anaemia or decrease of hemoglobin (e.g., participants with serious cardiovascular or cerebrovascular disease)
• History or presence of a serious mental disease, especially depression, which, in the investigator's opinion, does not allow administration of peginterferon alfa-2a (Pegasys®)
• History or presence of a disease consequent to immunodeficiency (e.g., inflammatory diseases of intestine, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (35)

Unknown Facility

Beroun, Czechia

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Unknown Facility

Brno, 62500, Czechia

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Chomutov, Czechia

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Česká Lípa, Czechia

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České Budějovice, 370 87, Czechia

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Děčín, 0, Czechia

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Havířov, Czechia

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Unknown Facility

Havlíčkův Brod, Czechia

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Hradec Králové, 500 12, Czechia

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Hradec Králové, Czechia

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Jablonec/nisou, 466 60, Czechia

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Jihlava, Czechia

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Karlovy Vary, Czechia

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Kolín, Czechia

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Liberec, Czechia

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Mělník, Czechia

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Most, Czechia

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Olomouc, Czechia

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Opava, Czechia

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Ostrava, 708 52, Czechia

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Pardubice, Czechia

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Prague, 00000, Czechia

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Prague, 128 08, Czechia

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Prague, 140 00, Czechia

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Prague, 180 01, Czechia

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Prague, Czechia

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Prostějov, Czechia

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Ústí nad Labem, Czechia

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Banská Bystrica, 957 17, Slovakia

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Bratislava, 833 05, Slovakia

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Bratislava, 851 07, Slovakia

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Košice, 040 01, Slovakia

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Košice, 04001, Slovakia

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Martin, 036 59, Slovakia

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Unknown Facility

Trenčín, 911 07, Slovakia

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: February 1, 2006
• Primary Completion: January 9, 2009
• Study Completion: January 9, 2009
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

CZ (28); SL (7)